Study of Hepatitis Eradication Receiving Protease Inhibitor Administration
The Study of Hepatitis Eradication Receiving Protease Inhibitor Administration
Sentara Norfolk General Hospital
50 participants
Mar 20, 2019
OBSERVATIONAL
Conditions
Summary
This is a prospective, non-blinded cohort study that will assess the safety, tolerability, and antiviral efficacy of glecaprevir/pibrentasivir therapy given post-discharge to HCV-negative recipients of HCV infected donors. Patients who meet entry criteria will be enrolled while on the transplant waitlist. At the time of transplant, some donors will be HCV positive / NAT positive and some will not be infected. Enrolled patients who receive an HCV negative donor will serve as contemporaneous controls. All study subjects who receive an HCV positive organ will be confirmed to have acquired HCV infection and genotype will be assessed prior to treatment with therapy.
Eligibility
Inclusion Criteria3
- Willing and capable of providing written informed consent
- Age ≥18 years
- On UNOS list as a candidate for heart transplant
Exclusion Criteria4
- Individuals under 18 years of age
- History of advanced liver disease, including active hepatitis B or C, detectable hepatitis B surface Ag, hepatitis B DNA, HCV RNA, or cirrhosis
- Pregnant individuals
- HIV antibody positive
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Interventions
12 weeks of oral open label glecaprevir/pibrentasivir (Dose 3 tablets daily per package label).
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03886077